Status:
NOT_YET_RECRUITING
Phase I Trial on the Safety of Delayed Infusion of a Naïve T Cell-Depleted Hematopoietic Graft With Memory T Cells in Solid Organ Transplant Recipients
Lead Sponsor:
Francisco Hernández Oliveros
Conditions:
Solid Organ Transplant Complications
Solid Organ Transplant Recipients
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to evaluate the safety and feasibility of inducing hematopoietic mixed chimerism to promote immune tolerance and potentially reduce the need for lifelong immunosuppr...
Detailed Description
This clinical trial is exploring a new way to help patients who receive a solid organ transplant-such as a kidney, lung, or intestine-live longer and healthier lives with fewer side effects from medic...
Eligibility Criteria
Inclusion
- Pediatric patients (\<18 years old) who are candidates to receive intestinal or lung transplantation (before SOT).
- Pediatric (\<18 years old) or adult patients (≥18 years old) who are either candidates for renal transplantation or have already undergone renal transplantation and remain candidates for subsequent HSCT.
- Patients who provide informed consent (or their legal guardians in the case of minors) before any study-related procedures.
- Recipients should have no active infectious disease or other medical condition that would contraindicate the combined transplantation procedure, as determined by the investigational team.
Exclusion
- Recipients with existing bone marrow disorders or those receiving medications known to adversely affect bone marrow function.
- Patients with advanced organ dysfunction (hepatic, cardiac, or pulmonary) incompatible with successful combined transplantation.
- Patients with active or uncontrolled autoimmune conditions that may interfere with transplantation and the induction of chimerism.
- Patients with known allergies to medications or products required for conditioning or transplantation.
- Patients with severe psychiatric or cognitive disorders that may interfere with adherence to study instructions or postoperative care.
- Patients currently enrolled in another clinical trial that could interfere with the outcomes or safety of this study.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Any other condition that, in the opinion if the Investigator, may interfere with the efficacy and/or safety evaluation of the trial.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06997471
Start Date
June 1 2025
End Date
June 1 2028
Last Update
May 30 2025
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